FDA Adverse Event
Malfunction
Summary report: N
NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM
MDR report key: 4889476
·
Received July 2, 2015
Report
- Report Number
- 6000034-2015-01403
- Event Type
- Malfunction
- Date Received
- July 2, 2015
- Date of Event
- July 1, 2015
- Report Date
- March 9, 2016
- Manufacturer
- COCHLEAR LTD .
- Product Code
- MHE
- PMA / PMN Number
- 000015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- AUDIOLOGIST
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
PER THE CLINIC, THE DEVICE WAS EXPLANTED (B(6) 2015, AND THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY. THIS REPORT IS FILED APRIL 1, 2016.
Additional Manufacturer Narrative · 1
CORRECTION; THE COMMON DEVICE NAME AND PRODUCT NAME IS MHE; AND NOT MCM AS PREVIOUSLY REPORTED.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF CONNECTION TO THE INTERNAL DEVICE. REPROGRAMMING ATTEMPTS WERE MADE; HOWEVER, THE ISSUE COULD NOT BE RESOLVED. THE IMPLANTED DEVICE REMAINS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 431036 | NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM | MHE | MHE | COCHLEAR LTD . | ABI24M |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 27 MO | Required Intervention |